Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
Purpose
The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease
Conditions
- COVID
- Sars-CoV2
- SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
- Oxidative Stress
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain
Exclusion Criteria
- Minors, pregnant women and people unable to provide informed consent are excluded from this study
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator NAC |
Patients receiving N-acetylcysteine (NAC) |
|
No Intervention Control |
Patients not receiving N-acetylcysteine (NAC) |
|
Recruiting Locations
More Details
- NCT ID
- NCT04419025
- Status
- Completed
- Sponsor
- Cambridge Health Alliance
Detailed Description
After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows: Inpatients: - N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge - N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge Outpatients: - N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks